Kornimate/medical-research-clean huggingface dataset:
surgery or chemoradiotherapy for cervical esophageal cancer

Conditions: Cervical Esophageal Cancer

Summary: to compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * patients with resectable cervical esophageal squamous cell carcinoma (ct1b-t4an0-3m0); * cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included; * aged 18-75 years; * without any contraindication of operation; * hemoglobin \>=90 g/l; leukocytes \>=4.0x10\^9/l; absolute neutrophil count \>=1.5x10\^9/l; platelet \>=100x10\^9/l;total bilirubin \ =50 ml/min (cocheroft-gault);inr \<=1.5 uln; aptt \<=1.5 uln; * without other malignancies; * expected r0 resection; * ecog ps 0-1; * volunteered to participate in the study, signed the informed consent form. exclusion criteria: * without other malignancies; * with mental diseases; * with hemorrhagic disease; * inoperable patients; * pregnant or lactating women; * has a history of allergy to paclitaxel or cisplatin

Keywords: esophageal neoplasm chemoradiotherapy esophagectomy overall survival
non--operative treatment of the medial malleolus in bi- and trimalleolar ankle fractures

Conditions: Ankle Malleolus Fracture Bimalleolar; Fracture of Medial Malleolus; Fracture of Ankle

Summary: the purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.


Eligibility criteria:
inclusion criteria: * patients with orthopaedic trauma association (ota) type 44 fractures (b2-3 and c2-3). exclusion criteria: * patients with ota type 43 distal tibia fractures. * patients with soft tissue injuries involving the medial malleolus.
drugs experience for adolescents with anorexia

Conditions: Anorexia Nervosa; Psychotropic Drugs; Adolescent

Summary: the purpose of this study is to access to the experiences of adolescents, their parents and healthcare professionals regarding psychotropic drugs in anorexia nervosa. no preconceived ideas (according to qualitative methods) but a question: what are the participants' perceptions and experiences of psychotropic drugs in anorexia nervosa? in an adolescent medicine department.

psychotropic prescription is common to adolescents suffering from anorexia nervosa. a first qualitative study (e3a protocol "experience of adolescents with anorexia nervosa toward antidepressants") looked at the experience of antidepressants among 15 adolescents suffering from anorexia nervosa. analysis of the interviews identified two meta-themes: 1. reactions to the proposal of antidepressant with an opposition phase (about the existence of depressive symptoms and about negative preconceptions) and need to share with family and other teenagers. 2. reactions to antidepressant use with ambivalence and an initial perception of coercion, and effects of antidepressants (psychological effects, effects on the body and on anorexia nervosa and effects perceived through the eyes of others). nine adolescents (out of 15) were also taking an atypical antipsychotic (apa) often prescribed in case of anorexia nervosa resistance. the need to share with family about the proposal of antidepressant and the effects perceived through the eyes of others (including parent's eyes) lead us to take an interest in parents perceptions. two decisive periods were identified: what do healthcare professionals think about psychotropic treatments for anorexia nervosa in adolescence? how do they propose treatment? interviewing teenagers, their parents as well as healthcare professionals, will enable to access to the complexity of representations and experiences of these psychotropic drugs in anorexia nervosa.

Eligibility criteria:
inclusion criteria: adolescents : * aged 12 to 25 years * suffering from anorexia nervosa (restrictive or mixed) according to dsm-5 (diagnostic and statistical manual) criteria * received psychotropic drugs (antidepressant treatment and/or apa) during their care, either ongoing or discontinued before this study started parents of adolescents suffering from anorexia nervosa for whom a psychotropic drug has been prescribed and whose adolescents meet inclusion criteria healthcare professionals working with adolescents suffering from eating disorders exclusion criteria: adolescents : * atypical eating disorder that does not meet the dsm-5 criteria for restrictive or mixed anorexia nervosa * bmi\<15 * prescription of an antidepressant other than an ssri (selective serotonin reuptake inhibitor) * prescription of an apa for the indication of psychotic symptoms

Keywords: adolescents anorexia nervosa psychotropic drugs qualitative research thematic analysis
beyond race: objectively assessed skin color and its association with pulse oximeter bias in critically ill infants

Conditions: Pulse Oximetry; Disparities; Infants

Summary: the overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (spo2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (sao2) across race and skin pigmentation. the main question that the investigators intend to answer is whether 1. there is greater pulse oximeter bias and subclinical hypoxemia in (1a) black compared to white infants, and (1b) dark versus light-pigmented infants 2. this bias increases with gestational and postnatal maturation 3. this bias is associated with adverse patient outcomes

the study investigators will conduct a prospective observational study involving 200 infants (0-3 months age) and compare simultaneously obtained pulse oximeter readings (spo2) and co-oximeter measured blood gas arterial oxygen saturation (sao2), among infants identified as non-hispanic black and non-hispanic white. the investigators will also obtain an objective assessment of skin pigmentation using a non-invasive device, skincolorcatch® (by delfin technologies ltd, finland) that provides (1) a melanin index and (2) an objective six-point categorization of skin color based on individual typology angle (ita). therefore, the investigators will measure the pulse oximeter bias (spo2-sao2) across infants identified as non-hispanic black and non-hispanic white, as well as among infants of various skin pigmentation. for infants that have an arterial line for more than one week, the researchers will measure pulse oximeter bias (spo2-sao2) on a weekly basis over time with skin maturation and pigmentation changes.

Eligibility criteria:
inclusion criteria: * signed informed consent * postnatal age less than 3 months corrected age * presence of an in-dwelling umbilical or peripheral arterial line * gestational age \>= 25 weeks exclusion criteria: * known skin pigmentary disorders * significantly impaired skin integrity * systemic bruising due to birth trauma * circulatory shock within last 48 hours * infants of peri-viable gestation (22-24 weeks)

Keywords: pulse oximeter bias disparities infants premature
two rebeccamycin analogue regimens in treating patients with advanced or recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer. purpose: randomized phase ii trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage iiib, stage iv, or recurrent non-small cell lung cancer.

objectives: * compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks. * compare the response duration in patients treated with these regimens. * compare the toxicity profiles of these two regimens in these patients. outline: this is a randomized, multicenter study. patients are stratified according to performance status (0 or 1 vs 2) and participating center. patients are randomized to one of two treatment arms. * arm i: patients receive rebeccamycin analogue iv over 1 hour on day 1. * arm ii: patients receive rebeccamycin analogue iv over 1 hour on days 1-5. treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

Eligibility criteria:
disease characteristics: * histologically proven stage iiib (with pleural effusions), iv, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen * measurable disease patient characteristics: age: * not specified performance status: * 0-2 life expectancy: * at least 12 weeks hematopoietic: * wbc at least 3,000/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin greater than 10 g/dl hepatic: * bilirubin no greater than 1.5 mg/dl * ast and alt less than 2 times normal renal: * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular: * no new york heart association class iii or iv heart disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no concurrent illness that would preclude study prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no more than 1 prior chemotherapy regimen * at least 4 weeks since prior chemotherapy endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no concurrent combination antiretroviral therapy for hiv

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
effectiveness of an online self-management intervention for type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes. the study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. the primary endpoint is the hba1c value six month after baseline.

the aim of this clinical trial is to investigate the effectiveness of the self-guided digital therapeutic covivio in 268 patients with type 2 diabetes mellitus (t2dm). patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (tau, n = 134), or to a control group, in which they will receive only tau (n = 134). the primary endpoint of this trial will be the between-groups difference of the hba1c in the intervention and control group at six months adjusted for the baseline hba1c. in order to show the course of change over time, two timepoints for assessment of effects are planned at four (t1) and six months (t2) after the baseline assessment (t0). the primary endpoint will be the hba1c at six months post-allocation. secondary endpoints will be depression, diabetes self-management (dsm), bmi, and quality of life. figure 1 (section 6.1) summarizes the design of the clinical trial.

Eligibility criteria:
inclusion criteria: * diagnosis of t2dm (submission of a medical certificate attesting to the presence of at least one of the following icd-10-gm diagnoses of t2dm: e11.20, e11.30, e11.40, e11.50, e11.60, e11.72, e11.74, e11.80, e11.90) * hba1c value ≥ 7.0% (53 mmol/mol) * bmi ≥ 23 kg/m2 * consent to participate * sufficient knowledge of the german language exclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) * change in medication, frequency of use or dosage (planned within 4 weeks before t0 or during the study period)

Keywords: type 2 diabetes covivio diabetes self-management digital health application
randomised double blind placebo controlled cross over design of the efficacy of topical morphine for inflammatory pain in children with epidermolysis bullosa

Conditions: Epidermylosis Bullosa

Summary: randomised double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with epidermolysis bullosa


Eligibility criteria:
inclusion criteria: * children under 18 years epidermolysis wounds requiring dressing changes
improvement in bronchial asthma in patients with extraesophageal reflux after acid suppression

Conditions: Bronchial Asthma; Gastroesophageal Reflux

Summary: the purpose of this study is to determine if 20mg bid of rabeprazole is effective in controlling gerd in patients with concomitant bronchial asthma and to assess improvement in asthma after reflux control.

gastroesophageal reflux disease has been considered as having a role in the course of asthma, as shown by the improvement of symptoms with adequate acid suppression therapy. it is important to consider and establish the presence of gerd in patients with asthma specially, those who fail to respond to conventional asthma management. it is believed that two mechanisms may play a role in the association between bronchial asthma and gerd, most commonly microaspiration of acid causing bronchoconstriction, the second being increased vagal tone. establishing an adequate and timely diagnosis and confirming or excluding a relationship between the two entities in asthmatic patients is the first step towards effective patient management. the next important consideration is establishing the correct acid suppression therapy and monitoring response to therapy with objective testing such as pulmonary function testing (pft) and esophageal ph testing. since there is not a real "normal" or physiologic reflux measure for patients with extresophageal manifestations as seen in patients with "classic" reflux where a total time of exposure to acid (ph \< 4) less than 5% is considered normal, in these patients it will be necessary to establish a more strict ph control than in those with classic gerd. achieving complete acid control in this population is expected to require higher doses of medication than those used in patients with classic reflux and no extraesophageal manifestations. thus we have developed this study in which we will assess the response to 20 mg bid dosing of rabeprazole measured by ph monitoring and then follow improvement in pulmonary function testing ( objective measure),as well as symptomatic response.

Eligibility criteria:
inclusion criteria: * moderate persistent or moderate severe bronchial asthma as determined by the study pulmonologist * gastroesophageal reflux disease exclusion criteria: * history of hypersensitivity to rabeprazole or its metabolites
safety/efficacy of systane free vs refresh liquigel

Conditions: Dry Eye

Summary: the objective of this study is to evaluate the safety and efficacy of systane free fid 105783 when compared to refresh liquigel lubricant eye drops (allergan) in a specified population of dry eye patients.


Eligibility criteria:
inclusion criteria: * \>/= 3 corneal staining score using nei scoring system. * need artificial tears at least some of the time. * other protocol-defined inclusion criteria may apply. exclusion criteria: * history or evidence of ocular or intraocular surgery in either eye within the past six months. * history of intolerance or hypersensitivity to any component of the study medication. * use of restasis within 30 days of visit 1. * participation in an investigational drug or device study within 30 days of entering this study. * other protocol-defined exclusion criteria may apply.
tms-fnirs personalized dosing

Conditions: Post Traumatic Stress Disorder; Traumatic Brain Injury

Summary: the intent of this study is to establish technical feasibility in a clinical population (ptsd, with or without mild tbi) of personalized tms-fnirs technology. thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (tms-fnirs) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of tms. personalized tms-fnirs technology will guide therapy for depression, post-traumatic stress disorder (ptsd), and/or traumatic brain injury (tbi)


Eligibility criteria:
inclusion criteria 1. adults ages 18-70 years. 2. eligible for consideration of treatment with tms for ptsd. 3. diagnosis of ptsd based on caps-5. 4. no changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study. 5. clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study exclusion criteria: 1. medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.). 2. unable to have an mri (e.g., due to ferrous metal or inability to tolerate). 3. active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment 4. dementia or other cognitive disorder making unable to engage in study. 5. any history or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other psychotic illness. 6. suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide. 7. ocd cannot be the primary disorder but can have ocd symptoms 8. taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.) 9. current, planned, or suspected pregnancy 10. unstable medical conditions or any current medical condition that could preclude being able to safely participate in tms treatment (e.g., unstable metabolic abnormality, unstable angina, etc.) 11. severe traumatic brain injury 12. prior tms treatment or already received tms as part of a study. 13. significant ongoing litigation or claims that impact research activities, as determined by the research study team. (research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation). we will exclude non-english speakers because of the need for rapid communication during the testing.
multi-center application of quantitative fit technology in colorectal cancer screening

Conditions: Colorectal Cancer Screening Fecal Immunochemical Test

Summary: in order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of fit positive judgment in line with the chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for chinese healthy population

feces were collected for quantitative fit test. those with positive results were further examined by colonoscopy. by comparing with pathological results of colonoscopy, the sensitivity, specificity, positive predictive value and negative predictive value of quantitative fit technology for the diagnosis of colorectal tumors were confirmed.

Eligibility criteria:
inclusion criteria: 1. healthy people aged 30 years and planning to undergo colonoscopy; 2. no history of gastrointestinal tumor; 3. no ulcerative colitis or crohn's disease; 4. no gastrointestinal hemorrhagic disease; 5. no history of gastrointestinal surgery, able to understand and willing to sign informed consent. exclusion criteria: 1. other serious diseases of the digestive tract, such as crohn's disease ulcerative colitis; 2. patients with gastric and esophageal cancer and other malignant tumors; 3. unable to cooperate after communication; 4. subjects who have received radiotherapy and chemotherapy; 5. other researchers believe that they are not suitable for inclusion in this clinical trial, such as mental illness patients, critical patients, pregnant women, illiterate minors, cognitive impairment pi, students of the researcher, pi, affiliated research units of the co-investigator or employees of the sponsor, etc
rhinovirus study with lactobacillus rhamnosus gg

Conditions: Respiratory Tract Infections [C08.730]

Summary: the purpose of this study is to evaluate the symptom impact of probiotic lactobacillus rhamnosus gg during rhinovirus infection.


Eligibility criteria:
inclusion criteria: 1. male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria) 2. age 18-65 years 3. serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus 4. no clinically significant finding on the pre-study nasal examination 5. females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, iud, surgical sterilization, abstinence, or condoms 6. written informed consent must be obtained at enrollment into the study exclusion criteria: 1. suffer from or have a history of significant allergic rhinitis at the time of study 2. bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema 3. nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation 4. pregnancy or lactation 5. history of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment 6. daily smoking within the past 2 years 7. use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment 8. previous participation in an experimental study with rhinovirus 39 9. allergy to any ingredient in the study product 10. have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject
evaluation of the ovarian reserve in infertile patients with endometriosis

Conditions: Endometriosis

Summary: comparison between ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility

comparison between ovarian reserve markers (laboratory or us) in patients with minimal/mild endometriosis and patients with tubal factor infertility including: cycle day 2 or 3 fsh and e2, serum amh and antral follicular count

Eligibility criteria:
inclusion criteria: age 18-35 years of age. written and signed informed consent by the patient to participate in the study. patients with regular menses, both ovaries, serum tsh within normal range, body mass index (bmi) \<30 kg/m2 with normal sperm analysis of the husband. exclusion criteria: patients with previous endocrine disorders. cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group). patient with previous surgery for endometriosis.